Breast Cancer in Men: About Clinical Trials

Approved by the Cancer.Net Editorial Board, 11/2016

ON THIS PAGE: You will learn more about clinical trials, which are the main way that new medical approaches are tested to see how well they work. To see other pages, use the menu.

What are clinical trials?

Researchers are always looking for better ways to care for patients with breast cancer. To make scientific advances, doctors create research studies involving volunteers, called clinical trials. In fact, every drug that is now approved by the U.S. Food and Drug Administration (FDA) was tested in clinical trials.

Many clinical trials focus on new treatments. Researchers want to learn if a new treatment is safe, effective, and possibly better than the treatments used now. These types of studies evaluate new drugs, different combinations of existing treatments, new approaches to radiation therapy or surgery, and new methods of treatment. Patients who participate in clinical trials can be some of the first to get a treatment before it is available to the public. However, there is no guarantee that the new treatment will be safe, effective, or better than what doctors use now.

Some clinical trials study new ways to relieve symptoms and side effects during treatment. Others study ways to manage the late effects that may happen a long time after treatment. Talk with your doctor about clinical trials for symptoms and side effects. There are also clinical trials studying ways to prevent cancer.

Deciding to join a clinical trial

Patients decide to participate in clinical trials for many reasons. For some patients, a clinical trial is the best treatment option available. Because standard treatments are not perfect, patients are often willing to face the added uncertainty of a clinical trial in the hope of a better result. Other patients volunteer for clinical trials because they know that these studies are the only way to make progress in treating breast cancer. Even if they do not benefit directly from the clinical trial, their participation may benefit future patients with breast cancer.

Sometimes people have concerns that, in a clinical trial, they may receive no treatment by being given a placebo or a “sugar pill.” However, placebos are usually combined with standard treatment in most cancer clinical trials. When a placebo is used in a study, it is done with the full knowledge of the participants. Find out more about placebos in cancer clinical trials.

Patient safety and informed consent

To join a clinical trial, patients must participate in a process known as informed consent, which is led by a doctor and research team. During informed consent, the doctor reviews all of the patient's options, so that the person understands the standard treatment, and how the new treatment differs from the standard treatment. The research team also reviews the risks of the new treatment, which may or may not be different from the risks of standard treatment. The team must also explain what will be required of each patient to participate in the clinical trial, including the number of health care provider visits, tests, and the schedule of treatment. Clinical trials also have certain criteria, called “eligibility criteria” that help structure the research and keep patients safe. These criteria are reviewed with you by the research team in detail. Although many clinical trials allow both men and women to enroll, some breast cancer clinical trials have eligibility criteria restricting a clinical trial to women only. It is important to discuss with your doctor whether a specific clinical trial allows both men and woman.

Insurance coverage of clinical trial costs differs by location and by study. In some programs, expenses associated with participating in the research, such as transportation and/or parking are reimbursed. It’s important to talk with the research team and your insurance company to learn about how the treatment in a clinical trial will be covered.

Patients who participate in a clinical trial may stop participating at any time for any personal or medical reason, including if the new treatment is not working or if there are serious side effects. Clinical trials are also closely monitored by experts who watch for any problems with each study. It is important that patients participating in a clinical trial talk with their doctor and researchers about who will be providing their treatment and care during the clinical trial, after the clinical trial ends, and/or if the patient chooses to leave the clinical trial before it ends.

Finding a clinical trial

Research through clinical trials is ongoing for all types of cancer. For specific topics being studied for breast cancer, learn more in the Latest Research section.

Cancer.Net offers a lot of information about cancer clinical trials in other areas of the website, including a complete section on clinical trials and places to search for clinical trials for a specific type of cancer.

In addition, this website offers free access to a video-based educational program about cancer clinical trials, located outside of this guide.

The next section in this guide is Latest Research. It explains areas of scientific research currently going on for this type of cancer. Or, use the menu to choose another section to continue reading this guide.